Myxoid LiposarcomaNCT04699292
International Prospective Registry on Local Treatment Approaches in MLS
An observational study of Myxoid Liposarcoma, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
To prospectively study commonly used local treatment approaches in Myxoid Liposarcoma (MLS) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myxoid Liposarcoma
- What is being tested?
- Surgery, Preoperative RT 36Gy and Preoperative RT 50Gy
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Jan 2021to Jan 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with Myxoid Liposarcoma (MLS) that will be treated in one of the participating Sarcoma Reference Centers according to one of the treatment approaches defined in the 5 cohorts.
Who may be able to join
- Age > 18 years
- Biopsy proven MLS, including the reciprocal chromosomal translocation t(12;16)(q13;p11)
- ECOG PS 0-2
- Written informed consent to share coded information in this international Registry
Who cannot join
- Prior radiotherapy to the target area
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
The Netherlands Cancer Institute
Amsterdam, 1066CX
Rick Haas, MD/PhD
Jules Lansu, MD/PhD
About this study
Official title: International Prospective Registry on Local Treatment Approaches in Myxoid Liposarcomas
To prospectively study commonly used local treatment approaches in Myxoid Liposarcoma (MLS)
Read the detailed description
In order to confirm the promising results of the 36 Gy dose level in the DOREMY trial (NCT02106312) and to compare outcome with other local treatment approaches.
- Conditions
- Myxoid Liposarcoma
- Being tested
- Surgery, Preoperative RT 36Gy, Preoperative RT 50Gy, Postoperative RT 50-66Gy, RT 36Gy
- Medical subject headings
- Liposarcoma, Myxoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Surgery
Preoperative RT 36GyRadiation
Preoperative radiotherapy to 36Gy (equivalent)
Preoperative RT 50GyRadiation
Preoperative radiotherapy to 50Gy (equivalent)
Postoperative RT 50-66GyRadiation
Postoperative radiotherapy to 50-66Gy (equivalent)
RT 36GyRadiation
Definitive radiotherapy to 36Gy (equivalent)
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | MLS patients managed by surgery only Receives: Procedure: Surgery | |
| Cohort B | MLS patients receiving preoperative RT to a dose of 36 Gy (equivalent) followed by surgery Receives: Procedure: Surgery; Radiation: Preoperative RT 36Gy | |
| Cohort C | MLS patients receiving preoperative RT to a dose of 50 Gy (equivalent) followed by surgery Receives: Procedure: Surgery; Radiation: Preoperative RT 50Gy | |
| Cohort D | MLS patients receiving surgery followed by postoperative RT to a dose of 50-66 Gy (equivalent) Receives: Procedure: Surgery; Radiation: Postoperative RT 50-66Gy | |
| Cohort E | MLS patients with oligometastatic and/or oligoprogressive disease receiving definitive RT to a dose of 36Gy (equivalent) Receives: Radiation: RT 36Gy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local recurrence free survival
Survival from surgery to local recurrence (event) or last follow-up
Measured: From surgery to the end of at least 5 years of follow-up
Secondary outcomes (2)
Wound complications
Any wound complication requiring intervention
Measured: From surgery to 6 months of follow-up
Late toxicity
Any grade ≥2 late (radiation-induced) toxicity according to CTCAE v5.0 toxicity criteria
Measured: From 3 months after surgery to the end of at least 5 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start18 Jan 2021
- Primary completionJan 2031 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myxoid LiposarcomaStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center, Maastro Clinic, The Netherlands, University Medical Center Groningen, Leiden University Medical Center, Vienna General Hospital, M.D. Anderson Cancer Center, University Hospital, Antwerp, Universitetssykehus, Haukeland University Hospital, Universitäts-Frauenklinik Graz, University Hospital Heidelberg, Mayo Clinic, Aarhus University Hospital, National Cancer Center, Japan, Princess Margaret Hospital, Canada, MOUNT SINAI HOSPITAL, University of Sydney, Institute for Cancer Research and treatment, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Institut Curie, Australia and New Zealand Sarcoma Association
- Responsible party
- Sponsor
- Investigators
- Rick Haas, MD/PhD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699292
- Sponsor's protocol ID
- M20DMY
- Other IDs
- IRBd20-354
- Status last verified
- Aug 2022
- First submitted
- 6 Jan 2021
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Prospective Registry on Local Treatment Approaches in Myxoid Liposarcomas
- ClinicalTrials.gov ID
- NCT04699292
- Acronym / sponsor ID
- M20DMY
- Conditions
- Myxoid Liposarcoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- Radboud University Medical Center, Maastro Clinic, The Netherlands, University Medical Center Groningen, Leiden University Medical Center, Vienna General Hospital, M.D. Anderson Cancer Center, University Hospital, Antwerp, Universitetssykehus, Haukeland University Hospital, Universitäts-Frauenklinik Graz, University Hospital Heidelberg, Mayo Clinic, Aarhus University Hospital, National Cancer Center, Japan, Princess Margaret Hospital, Canada, MOUNT SINAI HOSPITAL, University of Sydney, Institute for Cancer Research and treatment, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Institut Curie, Australia and New Zealand Sarcoma Association
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To prospectively study commonly used local treatment approaches in Myxoid Liposarcoma (MLS)
Detailed description
In order to confirm the promising results of the 36 Gy dose level in the DOREMY trial (NCT02106312) and to compare outcome with other local treatment approaches.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Procedure: SurgeryMLS patients managed by surgery only |
| Cohort B | – | Procedure: Surgery, Radiation: Preoperative RT 36GyMLS patients receiving preoperative RT to a dose of 36 Gy (equivalent) followed by surgery |
| Cohort C | – | Procedure: Surgery, Radiation: Preoperative RT 50GyMLS patients receiving preoperative RT to a dose of 50 Gy (equivalent) followed by surgery |
| Cohort D | – | Procedure: Surgery, Radiation: Postoperative RT 50-66GyMLS patients receiving surgery followed by postoperative RT to a dose of 50-66 Gy (equivalent) |
| Cohort E | – | Radiation: RT 36GyMLS patients with oligometastatic and/or oligoprogressive disease receiving definitive RT to a dose of 36Gy (equivalent) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Myxoid Liposarcoma (MLS) that will be treated in one of the participating Sarcoma Reference Centers according to one of the treatment approaches defined in the 5 cohorts.
Key inclusion criteria (4 listed)
- Age > 18 years
- Biopsy proven MLS, including the reciprocal chromosomal translocation t(12;16)(q13;p11)
- ECOG PS 0-2
- Written informed consent to share coded information in this international Registry
Key exclusion criteria (2 listed)
- Prior radiotherapy to the target area
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgerySurgery | Procedure or surgery | Cohort A, Cohort B, Cohort C, Cohort D |
| Preoperative RT 36GyPreoperative radiotherapy to 36Gy (equivalent) | Radiation | Cohort B |
| Preoperative RT 50GyPreoperative radiotherapy to 50Gy (equivalent) | Radiation | Cohort C |
| Postoperative RT 50-66GyPostoperative radiotherapy to 50-66Gy (equivalent) | Radiation | Cohort D |
| RT 36GyDefinitive radiotherapy to 36Gy (equivalent) | Radiation | Cohort E |
Primary outcome
Local recurrence free survival
Time frame: From surgery to the end of at least 5 years of follow-up
Survival from surgery to local recurrence (event) or last follow-up
2 secondary outcomes
Wound complications
Time frame: From surgery to 6 months of follow-up
Late toxicity
Time frame: From 3 months after surgery to the end of at least 5 years of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rick Haas, MD/PhD principal investigator
The Netherlands Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myxoid Liposarcoma, run by The Netherlands Cancer Institute at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rick Haas, MD/PhD (+31 20 512 9111, r.haas@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local recurrence free survival (time frame: From surgery to the end of at least 5 years of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2022.